| 10:30 a.m. – 11:40 a.m. |
Concurrent Panel Sessions |
Current public markets and the regulatory environment are challenging for late stage private and early stage public biotech companies. Biotech investors require an exit strategy as an essential part of the company’s business plan. Initial public offerings (IPO's) are not creating exits for private investors so mergers and acquisitions (M&A's) are becoming the preferred exit strategy for early stage investors. This shift to M&A as a dominant exit strategy and the need of big pharma to bolster their pipelines makes it difficult for companies to hold on to their products. Highly visible drug safety issues have Congress challenging the FDA to do more to protect patients. Join a lively panel discussion with industry leading investment bankers to look at the current industry and market dynamics and the strategies biotechnology companies are using to weather this perfect storm; challenging regulatory environment, turbulent markets, big pharma is shopping and maturation of the industry.
- J. Donald deBethizy, Ph.D., President and CEO, Targacept
- Maarten de Jong, Managing Director, Lehman Brothers Global Healthcare Group
- Jennifer Fox, Managing Director, Investment Banking Healthcare, Deutsche Bank
- Simon Gill, Managing Director and Co-head of U.S. Healthcare Investment Banking, RBC Capital Markets
Rare but severe adverse reactions to drugs represent a major challenge to the pharmaceutical industry. The FDA is increasingly focusing on “outliers” in clinical trials believing these adverse responses may predict post-marketing events. These events appear to result from both genetic and non-genetic factors which should be predictable. There will continue to be significant drug development and commercialization issues to consider as the science matures in this area.
- Reid J. Leonard, Ph.D., Executive Director, Licensing & External Research, Merck & Co, Inc.
- David Shoemaker, Ph.D., R.A.C., Senior Vice President, Global Regulatory Affairs and Pharmacovigilance, Pharmaceutical Product Development, Inc.
- Paul B. Watkins, M.D., Verne S. Caviness Professor of Medicine; Director, Translational and Clinical Sciences Institute UNC-Chapel Hill
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| 12 noon – 1 p.m. |
Concurrent Panel Sessions |
Traditionally, the early stages of biotechnology innovation have been funded through sweat equity, government grants, venture capital, licensing revenues and the public markets. This model is built on the assumption that later stages of development will be funded by large partners or by the public capital markets. But the public markets generally, and the IPO market in particular, has been lukewarm for biotech companies, putting downward pressure on the valuation of private companies and smaller cap public companies even while Big Pharma has been paying top dollar to acquire promising companies and programs.
Many companies respond to these market dynamics by selling the company, rather than accepting additional dilution and clinical stage risk.
Others are turning to new sources of capital to help finance research and development programs. Some of these investors are affiliated with existing pharma or biotech companies, and seek to leverage the development and financial resources of the parent to help grow portfolio companies to help fill the pipeline of the parent. Others bring project finance deal structures or other resources to help finance clinical development programs. Either way, clinical stage companies will want to explore the merits of non-traditional sources of capital.
- Michael P. Arlotto, Ph.D., Senior Vice President of Emerging Biotech, NovaQuest
- Wing Delatorre, M.D., M.B.A., Director, New Ventures, Biogen Idec
- David Pierson, Partner, Intersouth Partners
- Richard Soltero, Ph.D., President, PharmaDirections
- Alastair J.J. Wood, M.D., Managing Director, Symphony Capital
Biotechnology veterans will provide real-life cases of seeking, finding, operating, succeeding and failing business activities in diverse countries (focusing on examples from India, China, and Eastern Europe). From basic research, to protecting inventions, to product development, to marketing in foreign countries, the already complex issues of doing business in the US are magnified on the global stage. This magnification is a function of differences in language, culture, legal practices, time zones, business practices, and shear geographic distances.
- William (Bill) Barrett, Vice President, Intellectual Property, Advanced Liquid Logic, Inc.
- A.R. Kinney Horn, Business Development, Genentech, Inc.
- Ramana Kuchibhatla, Ph.D., President & CEO, Ventureast Pharmaceutical Services, LLC
- Brandon J. Price, Ph.D., Chief Executive Officer, GalenBio, Inc.
- Christopher Price, Ph.D., President and CEO, LaamScience, Inc.
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